R3 Vascular Secures WCG IRB Approval and CMS Category B Medicare Coverage for ELITE-BTK Pivotal Trial

January 17, 2025—R3 Vascular Inc. recently announced that it received WCG institutional review board (IRB) approval for the ELITE-BTK pivotal trial of its next-generation Magnitude drug-eluting bioresorbable scaffold for the treatment of below-the-knee peripheral arterial disease. The company stated that this approval allows the trial to take place at institutions that utilize WCG IRB as their central IRB in the United States.

Additionally, the company announced that the Centers for Medicare & Medicaid Services (CMS) has granted Category B approval for the investigational device exemption (IDE) study, ensuring Medicare coverage for the device, related and routine items, and services for the ELITE-BTK trial. In November 2024, R3 Vascular announced that the FDA granted IDE approval to initiate the trial.

The lead investigator for the ELITE-BTK pivotal trial is Eric A. Secemsky, MD, Director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

“R3 Vascular’s novel approach in the design of its next-generation bioresorbable drug-eluting scaffold is of great interest to the physician community and has the potential to transform the field of peripheral interventions,” commented Dr. Secemsky in the company’s press release. “We are eager to assess the impact of the Magnitude scaffold on patient outcomes, which is now even closer to reality with the completion of these latest important milestones.”

In May 2024, the company announced it closed a $87 million Series B financing round to support the ELITE-BTK IDE pivotal trial as well as additional research and development, global regulatory submissions, scale up of manufacturing processes, and initial commercialization.